The Pharmaceutical Risk Assessment Committee (PRAC) of the EMA Albert van der Zeijden (PRAC member) Expert representing patients perspective Eurordis Summerschool Friday June 5, 2015
Content The history of medicines regulation Composition of the PRAC Relationship with the CHMP and the CMDh PRAC activities A regular PRAC agenda Role of the patient-expert and patients involvement in PRAC procedures Public hearings How to follow the PRAC
History of Medicines Regulation and Pharmacovigilance 1930: The Food, Drug and Insecticide Administration becomes the Food and Drug Administration (USA) 1938: The Federal Food, Drug and Cosmatic Act introduced the requirement that safety has to be shown before selling the product 1963: Start of the current regulatory praxis in European countries and the USA after the thalidomide schandal 1995: European Medicines Evaluation Agency, now European Medicines Agency (EMA) 2010: New Pharmagovigilance Legislation in the EU, PRAC since July 2012
Directive 2010/84/EU and Regulation (EU) no 1235/2010 Pharmacovigilance rules are neccessary for the protection of public health in order to prevent, detect and assess adverse reactions to medicinal products placed on the Union market, as the full safety profile of medicinal products can only be known after they have been placed on the market.
Composition of the PRAC Chair 28 representatives: 1 of each member state 1 representative of Norway and 1 of Iceland 6 independant scientific experts 1 representative of patients and 1 of health care professionals 1 alternate per member Support of a secretariat Observer of the EU Commission
Relationship of PRAC with CHMP and CMDh Committee for Medicinal Products for Human use (CHMP): responsible for all centrally authorised medicinal products (CAP s) Committee for Mutual Recognition and decentralised procedure-human (CMDh): responsible for the coordination of nationally authorised products (NAP s) Own PRAC opinion on centrally authorised products: Advices to CHMP for CAP s and CMDh for products marketed in at least two memberstates
The activities of the PRAC Core business is the detection of signals and the assessment of the benefits and risks of medicines The Eudravigilance data-base, studies, opinions of other agencies (FDA) etc. Discussion of a potential signal in the PRAC Appointment of a rapporteur Assessment of the product(s) Routine Pharmacovigilance
A regular PRAC agenda (66 pages,209 items) EU referral procedures for safety reasons: urgent EU procedures (4 items) EU referral procedures for safety reasons: other EU referral procedures (11 items) Signal assessment and prioritisation (12 items) Risk Management Plans (RMP) (53 items) Periodic Safety Update Reports (PSUR) (35 items) and Periodic Safety Update Single Assessment (PSUSA) (3 items)
A regular PRAC meeting (2) Post Authorisation Safety Studies (PASS) 23 items Renewals of marketing authorisation, conditioal renewals and annual reassessments (15 items) Product related pharmacovigilance inspections (4 items) Other safety issues for discussion, requested by the CHMP, the EMA or member states (9 items) Organisational, regulatory and methodological matters (Orgam) (40 items)
Referrals and the Role of the PRAC A referral is a request of the European Union (EU) to conduct a scientific assessment of a particular medicine, or class of medicines. Safety related referrals are assessed by the PRAC and then either by the CHMP or the CMDh. All other referrals are assessed by the CHMP
Referral Procedures Article 107i: Urgent action is necessary because of a safety issue Article 20: CAP s in case of manufactory and safety issues Article 31: Concerns relating to quality, safety or efficacy issues Other referrals: Article 29; Article 13; Article 29(4) and Article 30
The Role of the Patient Expert Same as all other members with special expertise Add patients experience and perspectives to the expertice of regulators and other experts Bridging the gap between the statistical reality of the regulatory system and the personalised reality of clinical practice Is not and cannot be the watchdog of patients organisations: Confidentiality Agreement Contribute to the opinion building on benefit risk assessments of medicines, readability of texts like Package Leaflets (PL) and Dear Healthcare Professional Comunications (DHPC s)etc.
Involvement of patients in PRAC procedures Member and alternate of the PRAC (both reimbursed) Member of Scientific Advisory Group (SAG) The Prac asks advice of the Patients and Consumers Working Party (PCWP Involvement in a so-called special interest group A new instrument: the public hearing
Definition of Public Hearing A forum to which the public is invited to express its views and concerns on a pre-defined set of questions on issues related to the safety, whilst also considering the therapeutic effects of a particular medicine. A channel (for the PRAC) to take the public s views and concerns into account, particularly once all available data and evidence have been assessed and options for regulatory actions and risk management activities will need to be considered in a wider public health context.
Purpose of a Public Hearing within Referrals To seek public opinion, suggestions and recommendations on the acceptability of the risks associated with the medicine/class of medicines concerned, particularly in relation to its therapeutic effects and therapeutic alternatives as well as on the feasibility and acceptability of risk management and minimisations activities. To inform the debate of the PRAC, which continues to have the sole responsibility for giving its scientific recommendation on the safety of the medicine concerned.
More abot the Public Hearing Participants can attend in person, submit their contribution in writing or watch a live videstream. The sole language is English Open for all members of the public, but priority for representatives of groups of patients, health care professionals, academics etc Assessment report reflects how the outcome of the public hearing has impacted decision-making The public hearing will be held as a part of a PRAC meeting, MAH(s) are invited to present their views
Following the PRAC The agenda of the PRAC meeting available from the Tuesday after the start of the meeting The minutes of the PRAC meeting: a month after the meeting Highlights of the meeting the day after the meeting from 12.00 GMT Always available the meeting dates, the members and alternates and their Declaration Of Interest (DOI) and CV